Head of Global Regulatory Affairs and Strategy

Isomorphic Labs

5 days ago

4.4 on Glassdoor

Cambridge, MA

Hybrid

Full Time

Senior

0 applicants

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About this role

The Head of Global Regulatory Affairs and Strategy will lead regulatory strategy for all assets from IND to POC to registration and leverage AI to transform regulatory pathways. This senior leader will build the regulatory function, including Quality, Pharmacovigilance, and Medical Writing frameworks, and ensure programs are optimally positioned for rapid global approval.

Skills

Qualifications

Bachelor’s in life sciences or related fieldAdvanced scientific or pharmacy degree preferred15+ years in pharmaceutical/biotech industryExtensive experience leading programs from IND/CTA to NDA/BLA/MAAExperience with oncology and inflammation

About Isomorphic Labs

isomorphiclabs.com

Isomorphic Labs is an AI-driven drug discovery company that applies frontier machine learning to reimagine the drug discovery process. Building on advances such as DeepMind’s AlphaFold, it uses protein-structure prediction, generative modeling, and computational biology to uncover deeper biological insights, design candidate molecules, and accelerate target selection. The company develops an integrated computational platform and partners with biopharma to translate in silico predictions into experimental programs aimed at faster, de‑risked development of life‑changing medicines. Its teams combine machine learning, biology, and chemistry expertise to shorten discovery timelines and increase the pace of therapeutic breakthroughs.